Skip to main content
Clinical Trials/NCT04711785
NCT04711785WithdrawnNot Applicable

Assessment of the Possible Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise Tutored at Home Through an Integrated Computer System. Cohort Study

Hospital de la Ribera1 site in 1 countryStarted: September 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Intrinsic capacity

Study Overview

Brief Summary

The study has been designed to analyze the possible positive effects of a multicomponent physical exercise program monitored with an integrated electronic device system in dwelling-community frailty older adults.

The study will assess changes in physical, nutritional, cognitive, and psychological aspects after program finishes at six months.

Information will be collected by researchers at baseline, monthly and after study finishes.

Detailed Description

The aging process is associated with physiological changes that determine a decrease in functional reserve and limit the ability to respond to external factors.

Likewise, aging is associated with a deterioration of the regulatory processes that maintain the functional integration of the different organs and systems. A direct consequence of this phenomenon is the atypical presentation of highly prevalent diseases in the elderly. This atypical presentation of diseases in the elderly is responsible for the so-called geriatric syndromes, considered as specific nosological entities with a high frequency of presentation in the elderly, being included within the prevention, diagnosis and treatment strategies of geriatric medicine.

These syndromes can generate greater morbidity and consequences, sometimes more serious than the disease that produces them. Its systematic detection should be included in the anamnesis of the clinical history of the elderly. Geriatric syndromes are a group of conditions usually caused by the conjunction of diseases with a high prevalence in the elderly and which are the frequent origin of functional or social disability in the population. They are the manifestation of many diseases, but they are also the beginning of many other problems that we must take into account from their detection to establish a good prevention of them.

The hypothesis of this work is that in frail and pre-frail older adults who participate in an integrated program of multicomponent physical exercise tutored by means of an app will improve their functional situation and reverse their diagnoses of pre and frailty.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Cohort study no masking presented.

Eligibility Criteria

Ages
65 Years to 100 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Informed consent signature

Exclusion Criteria

  • •Life expectancy less than 6 months
  • •Acute Ischemic coronariopathy event during the last three months
  • •Active cancer treatment (chemoteraphy or radiotherapy) during the last three months
  • •Major surgery during the last six months

Arms & Interventions

Intervention

Active Comparator

Multicomponent exercise program twice a week (2 hours per week) during six months

Intervention: Multicomponent exercise program (Behavioral)

Control Goup

No Intervention

Usual routine.

Outcomes

Primary Outcomes

Intrinsic capacity

Time Frame: Six months

ICOPE questionnaire score

Frailty reversion.

Time Frame: Six months

Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail

Quality of life objective and subjective

Time Frame: Six months

EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.

Polypharmacy

Time Frame: Six months

Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.

Cognitive state

Time Frame: Six months

Pfeiffer questionnaire

Nutrition state

Time Frame: Six months

Mini Nutritional Assessment Short Form. Score 0 to 14.

Falls

Time Frame: Six months

Number of falls during follow-up period

Depression

Time Frame: Six months

Yesavage's Geriatrics Depression Scale (15 items)

Sarcopenia

Time Frame: Six months

European Working Group on Sarcopenia in Older People (EWGSOP) criteria

Secondary Outcomes

  • Validation of a gait speed mobile phone tool(Six months)
  • Validation of a shaking measurement tool to asses muscle strength(six months)
  • Hospital admissions(Six months)
  • Visits to General Practitioner (GP)(Six months)
  • Validation of a pulmonar capacity mobile phone tool(six months)

Investigators

Sponsor
Hospital de la Ribera
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Francisco Jose Tarazona-Santabalbina

MD, Ph D

Hospital de la Ribera

Study Sites (1)

Loading locations...

Similar Trials